Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

Phase 3CompletedNCT03946592

Daewoong Pharmaceutical Co. LTD.148 enrolled

Overview

Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

148

Conditions

Submental Fat

Interventions

Normal salineDRUG

Inject the Drug into submental fat via subcutaneous

DWJ211DRUG

Inject the Drug into submental fat via subcutaneous

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1. * Dissatisfaction with the submental area expressed by the subject as a rating of 1\~3 using the SSS as determinded on Visit 1. * Less than 35kg/m2 in body mass index on Visit1. * Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat. Exclusion Criteria: * History of any intervention to treat SMF * History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment. * Evidence of any cause of enlargement in the submental area. * History or current symptoms of dysphagia.

Locations (1)

Chung-ang university hospital

Seoul, South Korea

Outcomes

Primary Outcomes

PA-SMFRS, SA-SMFRS

Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment

Time frame: 12 week after last treatment

Data from ClinicalTrials.gov

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